Regulatory Affairs Specialist

Placements24; Mtubatuba Local Municipality; On-site; ZAR 600,000 - 900,000; Full time

Job summary

Placements24 is seeking a knowledgeable Regulatory Affairs Specialist to join our client’s Richards Bay team. The role focuses on preparing, submitting, and managing regulatory applications to ensure products meet evolving regulatory requirements across markets, contributing to patient safety and market access.

The successful candidate will have strong regulatory expertise, analytical skills, and experience with dossier preparation across major markets, aiming to support product development and

Qualifications

• Bachelor’s degree required; Master’s preferred.
• Minimum 5 years of pharmaceutical regulatory affairs experience.
• Strong knowledge of regulatory submission processes in key markets.
• Experience with dossier preparation and submission software.

Responsibilities

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals.
• Ensure compliance with health authority regulations (SAHPRA, FDA, EMA).
• Liaise with health authorities and provide timely responses to queries.
• Monitor regulatory changes and assess impact on products and strategies.
• Develop regulatory strategies to support development and commercialization.
• Maintain regulatory databases and document all regulatory activities.

Skills

Regulatory affairs

Pharma industry knowledge

Analytical thinking

Stakeholder communication

Education

Bachelor’s degree in Pharmacy, Law, Science

Master’s degree

Tools

Dossier submission software

Job description

Our client is seeking a knowledgeable and proactive Regulatory Affairs Specialist to join their team in Richards Bay. This role is essential for ensuring that all pharmaceutical products meet the complex and evolving regulatory requirements of the markets in which they are sold. You will be responsible for preparing, submitting, and managing regulatory applications, ensuring compliance throughout the product lifecycle. This position offers a challenging and rewarding career path within a key industry, contributing to patient safety and market access for vital medications. The successful candidate will possess strong analytical skills and a deep understanding of pharmaceutical regulations.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new product registrations, variations, and renewals in various international markets.
• Ensure compliance with relevant health authority regulations, guidelines, and standards (e.g., SAHPRA, FDA, EMA).
• Liaise with health authorities, providing timely responses to queries and requests.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Develop and implement regulatory strategies to support product development and commercialization.
• Maintain regulatory databases and ensure accurate record-keeping for all regulatory activities.

Requirements

• Bachelor's degree in Pharmacy, Law, Science, or a related field.
• A Master's degree is a plus.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory submission processes and requirements in key markets.
• Experience with dossier preparation and submission software.